Saliva as Source of Detection for SARS-CoV-2

Evaluation of Saliva as Source of Detection for SARS-CoV-2

Background:

Nasopharyngeal (NP) swabbing is being used to test for SARS-CoV-2 infection. For this, a swab is inserted deep into the back of the nose to collect a sample. It can cause discomfort for most people. Researchers want to find an easier way to collect samples.

Objective:

To learn if testing for SARSCoV-2 with a saliva sample only, a nasal swab from just the front part of the nostril only, or a saliva sample plus a nasal swab gives results that are as accurate as the NP swab.

Eligibility:

NIH staff members age 18 and older who are taking part in NIH CC SARS-CoV-2 surveillance.

Design:

The Occupational Medical Service (OMS) collects NP swabs as part of standard NIH staff screening. Participants will give 1 or 2 saliva samples and 1 or 2 nasal swabs when their NP swab is collected by OMS. If their NP swab was already collected, their OMS record will be reviewed for the result.

If the NP swab result is positive, the participant will have another NP swab. At that time, they will also give 1 or 2 saliva samples and 1 or 2 nasal swabs. If the NP swab result is negative, they will give 1 or 2 saliva samples and 1 or 2 nasal swabs the next time they have an NP swab.

For the saliva sample, participants will spit into a tube.

For the nasal swab, the inside of the front part of the nostril will be swabbed.

Participation ends after the study samples are collected. Participants can choose to keep giving saliva and nasal swab samples each time they have an NP swab.

Study Overview

• Status: Completed
• Conditions: COVID-19

Detailed Description

Because of the inconvenience of nasopharyngeal (NP) testing for SARS-CoV-2 detection, we are interested in identifying different strategies for detecting infection. A technique that is less intrusive would put individuals undergoing testing at lower risk for complications, would likely increase compliance with subsequent tests, and would decrease risk to the providers who are conducting the test. For asymptomatic screening, some institutions are using midturbinate swabs instead of NP swabs, for increased compliance due to decreased discomfort. The NIH has switched to midturbinate collection in asymptomatic collections only. A test that would require only expectorating saliva and/or collection of a midturbinate swab would address the issues of NP collection discomfort. Saliva is the most preferred by patients or asymptomatic staff due to no collection in the nasal cavity at all. Although the CDC lists midturbinate swab as an acceptable specimen type, there are minimal data about the sensitivity of this collection for SARS-CoV-2, and decisions to use midturbinate swabs are based in part on experience with other respiratory viruses. Also, if saliva were found to be equivalent to NP for patient testing, there will be a benefit to future patients in providing this option for testing. Therefore, we propose to validate these sample types for SARS-CoV-2 detection. The RT-PCR results based on a saliva sample alone or a saliva sample coupled with a midturbinate swab, will be correlated with the results using surveillance or diagnostic swab samples to validate their use for SARS-CoV-2 detection.

• Study Type: Observational
• Enrollment (Actual): 456

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

NIH staff undergoing standard NIH COVID-19 screening

Description

• INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all of the following criteria:

1. Is one of the following:

   1. An NIH staff member participating in NIH CC SARS-CoV-2 surveillance, or
   2. A WHC patient who had or is having a diagnostic NP RT-PCR test for SARS-CoV-2.
2. Age greater than or equal to 18 years.
3. Able to provide informed consent.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Inability or unwillingness to have NP sampling or midturbinate sampling (applies to NIH site only).
2. Inability or unwillingness to provide saliva sample (applies to both NIH and WHC sites).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
NIH staff; NIH staff undergoing standard NIH COVID-19 screening willing to donate additional research samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Saliva SARS-CoV-2 RT-PCR test results	Validate saliva or nasal swab as a source of detection for SARS-CoV-2.	Screening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Saliva and midturbinate swab SARS-CoV-2 RT-PCR test results	Validate saliva coupled with a nasal swab as a source of detection for SARS-CoV-2.	Screening

Collaborators and Investigators

• Sponsor: National Institutes of Health Clinical Center (CC)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 13, 2020
• Primary Completion (ACTUAL): September 4, 2020
• Study Completion (ACTUAL): September 4, 2020

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (ACTUAL): June 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Coronavirus; COVID-19; Severe Acute Respiratory Syndrome Coronavirus 2; SARS-CoV-2 RT-PCR
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 200128; 20-CC-0128